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ERIVEDGE Drug Patent Profile

When do Erivedge patents expire, and when can generic versions of Erivedge launch?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-four patent family members in twenty-four countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

DrugPatentWatch^® Generic Entry Outlook for Erivedge

Erivedge was eligible for patent challenges on January 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ERIVEDGE

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	46
Patent Applications:	1,341
Drug Prices:	Drug price information for ERIVEDGE
What excipients (inactive ingredients) are in ERIVEDGE?	ERIVEDGE excipients list
DailyMed Link:	ERIVEDGE at DailyMed

See drug prices for ERIVEDGE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERIVEDGE

Constraining patent/regulatory exclusivity:

7,888,364

NDA:

203388

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ERIVEDGE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Genentech, Inc.	Early Phase 1
H. Lee Moffitt Cancer Center and Research Institute	Early Phase 1
Ronald Buckanovich	Phase 2

See all ERIVEDGE clinical trials

Pharmacology for ERIVEDGE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for ERIVEDGE

ERIVEDGE is protected by three US patents.

This potential generic entry date is based on patent 7,888,364.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	9,278,961
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	9,790,183
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	7,888,364		Y	Y

EU/EMA Drug Approvals for ERIVEDGE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Erivedge	vismodegib	EMEA/H/C/002602 Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	Authorised	no	no	no	2013-07-12	2013-04-26

International Patents for ERIVEDGE

See the table below for patents covering ERIVEDGE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1789390	INHIBITEURS PYRIDYLES DE LA SIGNALISATION HEDGEHOG (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Australia	2011201229	Pyridyl Inhibitors of Hedgehog Signalling
Brazil	PI0514841	inibidores de piridila da sinalização de hedgehog, processo de preparação dos mesmos e composição compreendendo os referidos inibidores
Japan	5143558
Norway	20071719
China	102964294	Pyridyl inhibitors of hedgehog signalling
Japan	2008511675

Supplementary Protection Certificates for ERIVEDGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	PA2013024	Lithuania		PRODUCT NAME: VISMODEGIBUM; NAT. REGISTRATION NO/DATE: SWISS 62497 01 20130530; FIRST REGISTRATION: EU/1/13/848 20130712
1789390	CA 2013 00050	Denmark		PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530
1789390	2014/002	Ireland		PRODUCT NAME: ERIVEDGE-VISMODEGIB OR A SALT OR SOLVATE THEREOF; NAT REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION NO/DATE: 62497 01 20130530
1789390	50/2013	Austria		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: EU/1/13/848 (MITTTEILUNG) 20130717
1789390	122013000074	Germany		PRODUCT NAME: ERIVEDGE - VISMODEGIB; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: SCHWEIZ IKS-NR. 62497 20130530
1789390	C20130027 00083	Estonia		PRODUCT NAME: VISMODEGIIB;REG NO/DATE: K(2013)4550 (LOPLIK) 12.07.2013
1789390	170 12-2013	Slovakia		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: EU/1/13/848/001 20130712

Market Dynamics and Financial Trajectory for Erivedge (Vismodegib)

Introduction to Erivedge

Erivedge (vismodegib) is a groundbreaking drug that inhibits the Hedgehog pathway, specifically designed for the treatment of advanced basal cell carcinoma (BCC) in adults. Developed by Genentech and Curis, and marketed by Genentech in the US, Chugai Pharmaceuticals in Japan, and Roche globally, Erivedge has carved a unique niche in the oncology market[1].

Approval and Regulatory Status

Erivedge was approved by the FDA in January 2012, marking it as the first drug specifically indicated for the treatment of advanced BCC. This approval was a significant milestone, especially for patients who are not candidates for surgery. The drug also underwent a marketing authorisation application (MAA) in the European Union, further expanding its global reach[1].

Market Positioning

As the first drug available for the treatment of advanced BCC, Erivedge holds a prime position in the market with no direct competitors. This exclusivity has been a key factor in its market success, providing a viable alternative for patients who cannot undergo surgical interventions[1].

Financial Performance

Revenue and Royalties

Curis, the partner company involved in the development of Erivedge, generates revenue primarily from royalties on the net sales of the drug by Genentech and Roche. In 2022, Curis reported $10.2 million in revenue, mostly comprising royalty revenues from Erivedge sales. This figure is slightly lower than the $10.6 million reported in 2021. The fourth quarter of 2022 saw $2.9 million in revenue from royalties, down from $3.1 million in the same period of 2021[5].

Milestone Payments and Royalties

Following the FDA approval of Erivedge, Curis received a $10 million milestone payment from Genentech. Additional milestone payments are expected if the marketing authorisation application in the EU is approved. Curis is also entitled to royalties from future sales of Erivedge, which has been a steady source of income for the company[1].

Market Dynamics

Drivers

Increasing Prevalence of Basal Cell Carcinoma

The rising prevalence of basal cell carcinoma, driven by factors such as chronic infections, history of skin cancer, exposure to specific chemicals, skin inflammations, smoking, and UV exposure, is a significant driver for the hedgehog pathway inhibitors market. According to the American Cancer Society, over 5.4 million people worldwide are diagnosed with squamous and basal cell skin cancer each year, with basal cell carcinoma being the most common type[4].

Healthcare Infrastructure and Awareness

Increasing healthcare expenditure and improvements in healthcare infrastructure are also driving the growth of the hedgehog pathway inhibitors market. Public and private initiatives to raise awareness about skin cancers and the availability of treatments like Erivedge further contribute to market expansion[4].

Opportunities

Research and Development Activities

The hedgehog pathway inhibitors market is fueled by an increase in research and development activities. New drug approvals and launches, along with investments in advanced technologies, provide beneficial opportunities for market growth. The ongoing research in this area is expected to lead to more effective treatments and expand the market further[4].

Restraints and Challenges

Despite the growth potential, the market faces challenges such as the high development and approval costs associated with cancer drugs. Although hedgehog pathway inhibitors have relatively lower development costs compared to other oncology drugs, the overall financial burden remains significant. Additionally, the impact of biosimilar competition on established drugs can affect the market dynamics, though Erivedge's unique indication helps it maintain a strong position[3][4].

Market Size and Growth

The global hedgehog pathway inhibitors market, which includes Erivedge, was valued at USD 531.39 million in 2021 and is expected to reach USD 840.58 million by 2029, growing at a CAGR of 5.90% during the forecast period. This growth is driven by the increasing prevalence of basal cell carcinoma and other related cancers, as well as the preference for painless treatments like hedgehog pathway inhibitors[4].

Key Takeaways

• First-in-Class Treatment: Erivedge is the first FDA-approved drug for the treatment of advanced basal cell carcinoma.
• Market Exclusivity: It holds a unique market position with no direct competitors.
• Revenue Stream: Curis generates revenue primarily from royalties on Erivedge sales.
• Growing Market: The hedgehog pathway inhibitors market is expected to grow significantly due to increasing cancer prevalence and healthcare infrastructure improvements.
• Research and Development: Ongoing R&D activities are crucial for the market's growth and the development of new treatments.

FAQs

What is Erivedge used for?

Erivedge (vismodegib) is used for the treatment of advanced basal cell carcinoma (BCC) in adults.

Who developed and markets Erivedge?

Erivedge was developed by Genentech and Curis, and it is marketed by Genentech in the US, Chugai Pharmaceuticals in Japan, and Roche globally.

What was the significance of Erivedge's FDA approval?

Erivedge was the first drug to be approved by the FDA for the treatment of advanced BCC, providing a new treatment option for patients who cannot undergo surgery.

How does Curis benefit financially from Erivedge?

Curis benefits from royalties on the net sales of Erivedge by Genentech and Roche, as well as milestone payments related to regulatory approvals.

What are the key drivers of the hedgehog pathway inhibitors market?

The key drivers include the increasing prevalence of basal cell carcinoma, improvements in healthcare infrastructure, and ongoing research and development activities.

Sources

1. Clinical Trials Arena: Erivedge (vismodegib) – Treatment for Advanced Basal Cell Carcinoma[1].
2. Roche Finance Report 2023: IFRS net income and core earnings per share[2].
3. ASPE Report: Antimicrobial Drugs Market Returns Analysis[3].
4. Data Bridge Market Research: Global Hedgehog Pathway Inhibitors Market – Industry Trends and Forecast to 2029[4].
5. PR Newswire: Curis Provides Fourth Quarter 2022 Business Update[5].